A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Chugai Pharmaceutical
122 participants
Oct 8, 2025
INTERVENTIONAL
Summary
This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.
Eligibility
Inclusion Criteria7
- Aged \>18 years at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Histologically documented extensive stage small cell lung cancer
- Disease recurrence documented after at least one prior systemic therapy.
- Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
- Measurable disease per RECIST v.1.1.
- Adequate hematologic and end organ function
Exclusion Criteria11
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
- History or complication of clinically significant autoimmune disease
- a positive HIV antibody test at screening
- Active hepatitis B or hepatitis C
- Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
- Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
- History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
- Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
- Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
- History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
- Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)
Interventions
Obinutuzumab as an IV infusion
ALPS12 as an IV infusion
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07107490